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Betadine ophthalmic prep solution
Betadine ophthalmic prep solution is an iodine-based antiseptic that kills microorganisms through oxidative damage to cellular proteins and nucleic acids.
Betadine ophthalmic prep solution is an iodine-based antiseptic that kills microorganisms through oxidative damage to cellular proteins and nucleic acids. Used for Preoperative antiseptic preparation of the ocular surface and periocular skin prior to ophthalmic surgery.
At a glance
| Generic name | Betadine ophthalmic prep solution |
|---|---|
| Sponsor | Altacor Ltd. |
| Drug class | Topical antiseptic/antimicrobial |
| Target | Microbial proteins and nucleic acids (non-selective oxidative mechanism) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology / Infection Prevention |
| Phase | Phase 3 |
Mechanism of action
Povidone-iodine (the active ingredient in Betadine) releases free iodine when applied topically, which penetrates microbial cell membranes and denatures essential proteins and DNA/RNA. This broad-spectrum antimicrobial action is effective against bacteria, viruses, fungi, and some protozoa. The solution is used preoperatively to reduce the microbial load on the ocular surface and surrounding tissues, thereby reducing the risk of surgical site infections.
Approved indications
- Preoperative antiseptic preparation of the ocular surface and periocular skin prior to ophthalmic surgery
Common side effects
- Ocular irritation
- Conjunctival hyperemia
- Transient stinging or discomfort
- Allergic reaction (iodine sensitivity)
Key clinical trials
- Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers (PHASE3)
- The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia. (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Betadine ophthalmic prep solution CI brief — competitive landscape report
- Betadine ophthalmic prep solution updates RSS · CI watch RSS
- Altacor Ltd. portfolio CI